Stability Coordinator

Rensselaer, New York, US
May 18, 2018
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Performs a variety of activities to administer the stability program and manage data generated in support of the company's quality program.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Coordinates with other departments to identify material to be put on stability.
• Authors stability protocols and obtains necessary approvals prior to study initiation.
• Performs review of analytical data and compiles into a central database.
• Provides stability data necessary for the submission of various regulatory documents.
• Provides stability data to other departments upon request.
• Works with management and Stability Technicians in the acquisition of stability chambers and related equipment, as needed.
• In conjunction with the Stability Technician, oversees the integrity of stability chamber inventory for their projects.
• Assures that samples are removed from chambers according to protocol pull schedules and submitted to appropriate testing group.
• Is responsible for the preparation of samples for inclusion in stability studies (aliquotting, labeling, distribution to appropriate stability chamber), utilizing the Stability Technicians and current procedures.
• Interacts with outside customers or functional peer groups.
• May be responsible for maintaining a specific project.
• Complies with all pertinent regulatory agency requirements.
• Participates in required training activities.

Knowledge and Skills:
• Excellent written and oral communication skills.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Ability to organize and maintain data or information.
• Ability to learn through observation and hands on experience.

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Ability to learn and follow routine procedures independently

• Basic troubleshooting skills

• Identify and communicate continuous improvement ideas

• Ability to work in an every-changing environment

• Build and maintain working relationships

• Goes above and beyond by demonstrating proficiencies with assigned tasks

Education and Experience:
• Requires BS/BA in Life Sciences or related field. Prior industry or stability experience is preferred.

* Level will be determined based upon experience

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 12892BR